Abstract

Objectives

Real-world evidence (RWE) studies are increasingly being used to support healthcare decisions. Various frameworks, tools, and checklists exist for ensuring quality of real-world data, designing robust studies, and assessing potential for bias. In January 2021, Structured Template and Reporting Tool for RWE (STaRT-RWE) was released to further reduce ambiguity, assumptions, and misinterpretation while planning, implementing, and reporting RWE studies of the safety and effectiveness of treatments. The objective of this study was to identify gaps in the reporting quality of published RWE studies by using this template for critical appraisal.

Methods

Two reviewers conducted a keyword search on PubMed for free-full-text research articles using real-world data, RWE design, and safety with or without effectiveness outcomes of a medicinal product or intervention in humans of any age or gender, published in English between January 13, 2021, and January 13, 2022. Assessment of risk of bias was done using Assessment of Real-World Observational Studies critical appraisal tool. Deficiencies in methods and findings as per STaRT-RWE template were reported as frequencies.

Results

A total of 54 of 2374 retrieved studies were included in the review. Based on the STaRT-RWE template, the studies inadequately reported empirically defined covariates, power and sample size calculation, attrition, sensitivity analyses, index date (day 0) defining criterion, predefined covariates, outcome, metadata about data source and software, objective, inclusion and exclusion criteria, analysis specifications, and follow-up.

Conclusions

The use of STaRT-RWE template along with its tables, design diagram, and library of published studies has a potential of improving robustness of RWE studies.